|
Device | Roche cobas BRAF V600 Mutation Test |
Generic Name | Somatic gene mutation detection system |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P110020 |
Supplement Number | S041 |
Date Received | 12/07/2023 |
Decision Date | 12/21/2023 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for described labeling changes in an update to the hazard information on the product labeling for cobas® KRAS Mutation Test and the cobas® DNASample Preparation Kit. |